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510(k) Data Aggregation
K Number
K102479Device Name
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2011-06-02
(276 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Device Description
The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
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K Number
K071682Device Name
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
Manufacturer
Date Cleared
2007-08-15
(57 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography.
Device Description
The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser; CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.
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K Number
K062390Device Name
CRYSTALVIEW R200
Manufacturer
Date Cleared
2006-09-18
(33 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
Device Description
The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware. The modification reported in this submission replaces the integrated third-party image enhancement software with image enhancement software developed by Alara.
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K Number
K061538Device Name
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
Manufacturer
Date Cleared
2006-06-30
(28 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
Device Description
The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a QC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 OC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and postprocessing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
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K Number
K032210Device Name
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2003-10-02
(73 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
Device Description
The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
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K Number
K000162Device Name
METRISCAN BONE DENSITY SYSTEM
Manufacturer
Date Cleared
2000-05-12
(114 days)
Product Code
Regulation Number
892.1170Why did this record match?
Applicant Name (Manufacturer) :
ALARA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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